Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial
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Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. / Bendszus, Martin; Fiehler, Jens; Subtil, Fabien; Bonekamp, Susanne; Aamodt, Anne Hege; Fuentes, Blanca; Gizewski, Elke R; Hill, Michael D; Krajina, Antonin; Pierot, Laurent; Simonsen, Claus Z; Zeleňák, Kamil; Blauenfeldt, Rolf A; Cheng, Bastian; Denis, Angélique; Deutschmann, Hannes; Dorn, Franziska; Flottmann, Fabian; Gellißen, Susanne; Gerber, Johannes C; Goyal, Mayank; Haring, Jozef; Herweh, Christian; Hopf-Jensen, Silke; Hua, Vi Tuan; Jensen, Märit; Kastrup, Andreas; Keil, Christiane Fee; Klepanec, Andrej; Kurča, Egon; Mikkelsen, Ronni; Möhlenbruch, Markus; Müller-Hülsbeck, Stefan; Münnich, Nico; Pagano, Paolo; Papanagiotou, Panagiotis; Petzold, Gabor C; Pham, Mirko; Puetz, Volker; Raupach, Jan; Reimann, Gernot; Ringleb, Peter Arthur; Schell, Maximilian; Schlemm, Eckhard; Schönenberger, Silvia; Tennøe, Bjørn; Ulfert, Christian; Vališ, Kateřina; Vítková, Eva; Vollherbst, Dominik F; Wick, Wolfgang; Thomalla, Götz; TENSION Investigators.
in: LANCET, Jahrgang 402, Nr. 10414, 11.11.2023, S. 1753-1763.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial
AU - Bendszus, Martin
AU - Fiehler, Jens
AU - Subtil, Fabien
AU - Bonekamp, Susanne
AU - Aamodt, Anne Hege
AU - Fuentes, Blanca
AU - Gizewski, Elke R
AU - Hill, Michael D
AU - Krajina, Antonin
AU - Pierot, Laurent
AU - Simonsen, Claus Z
AU - Zeleňák, Kamil
AU - Blauenfeldt, Rolf A
AU - Cheng, Bastian
AU - Denis, Angélique
AU - Deutschmann, Hannes
AU - Dorn, Franziska
AU - Flottmann, Fabian
AU - Gellißen, Susanne
AU - Gerber, Johannes C
AU - Goyal, Mayank
AU - Haring, Jozef
AU - Herweh, Christian
AU - Hopf-Jensen, Silke
AU - Hua, Vi Tuan
AU - Jensen, Märit
AU - Kastrup, Andreas
AU - Keil, Christiane Fee
AU - Klepanec, Andrej
AU - Kurča, Egon
AU - Mikkelsen, Ronni
AU - Möhlenbruch, Markus
AU - Müller-Hülsbeck, Stefan
AU - Münnich, Nico
AU - Pagano, Paolo
AU - Papanagiotou, Panagiotis
AU - Petzold, Gabor C
AU - Pham, Mirko
AU - Puetz, Volker
AU - Raupach, Jan
AU - Reimann, Gernot
AU - Ringleb, Peter Arthur
AU - Schell, Maximilian
AU - Schlemm, Eckhard
AU - Schönenberger, Silvia
AU - Tennøe, Bjørn
AU - Ulfert, Christian
AU - Vališ, Kateřina
AU - Vítková, Eva
AU - Vollherbst, Dominik F
AU - Wick, Wolfgang
AU - Thomalla, Götz
AU - TENSION Investigators
N1 - Copyright © 2023 Elsevier Ltd. All rights reserved.
PY - 2023/11/11
Y1 - 2023/11/11
N2 - BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice.METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.FUNDING: EU Horizon 2020.
AB - BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice.METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.FUNDING: EU Horizon 2020.
U2 - 10.1016/S0140-6736(23)02032-9
DO - 10.1016/S0140-6736(23)02032-9
M3 - SCORING: Journal article
C2 - 37837989
VL - 402
SP - 1753
EP - 1763
JO - LANCET
JF - LANCET
SN - 0140-6736
IS - 10414
ER -